Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals

King Faisal Specialist Hospital & Research Center

Status and phase: Terminated; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT01170468

RAC 2101040

Details and patient eligibility

About

Both vitamin D deficiency and type II DM/prediabetes are highly prevalent. Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. A cause-effect relationship between vitamin D deficiency and the development of type II DM has not been established.

The investigators plan to conduct a 2 year, double blind, randomized, placebo controlled trial on the effect of vitamin D3 supplement on the incidence of type II DM in high risk individuals.

Enrollment: 25 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Adults living in Riyadh area with impaired fasting glucose or/and impaired glucose tolerance (prediabetics) and total 25 OH vitamin D level between 10-30 nmol/l
• Who consume no more than one serving of milk/day
• Do not take vitamin supplement
• Habitually have less than 10 hour of sun exposure per week
• Don't suffer from granulomatus conditions, liver disease, kidney disease, or diabetes
• Don't take anticonvulsants, barbiturates, steroids, or antidiabetic medications.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

Vitamin D3

Experimental group

Description:

Vitamin D3 5000 IU daily

Treatment:

Drug: Vitamin D3

Placebo

Placebo Comparator group

Description:

Placebo daily

Treatment:

Drug: Placebo